Left Ventricular Dysfunction
Conditions
Keywords
Pacing
Brief summary
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
Detailed description
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.
Interventions
DEVICECRT-D
Left Ventricular MultiSite Pacing
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed. 2. Subjects must meet BSC labeled indication for CRT-D implantation. 3. Subjects must have a functional RA lead and RV lead implanted 4. Subjects who are willing and capable of providing informed consent 5. Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol 6. Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation. 2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment 3. Subjects with documented history of permanent AF 4. Subjects with documented permanent complete AV block 5. Subjects who are expected to receive a heart transplant during the 12 months course of the study 6. Subjects with documented life expectancy of less than 12 months 7. Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV MSP Feature Related Complication-Free Rate | Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration. | Proportion of subjects free from LVMSP feature related complications at 12 months |
| Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months | 12 Month Follow Up | Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
CRT-D: Left Ventricular MultiSite Pacing | 583 |
| Total | 583 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 19 |
| Overall Study | Withdrawal by Subject | 76 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 66.7 Years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 95 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) White | 460 Participants |
| Region of Enrollment United States | 583 participants |
| Sex: Female, Male Female | 211 Participants |
| Sex: Female, Male Male | 372 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 584 |
| other Total, other adverse events | 72 / 584 |
| serious Total, serious adverse events | 131 / 584 |
Outcome results
Primary
LV MSP Feature Related Complication-Free Rate
Proportion of subjects free from LVMSP feature related complications at 12 months
Time frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Population: Subjects who are non-responders at the 6 month follow up and who have LVMSP enabled for for any duration between the 6th and 12 month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | LV MSP Feature Related Complication-Free Rate | 99 percentage of participants |
Comparison: The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.~H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.~The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis.
Primary
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.
Time frame: 12 Month Follow Up
Population: Non-responders at 6 Months who had LV MSP enabled and had complete clinical composite score data, LV MSP on and achieved \>93% LVa and LVb pacing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months | 51.3 percentage of participants |
Comparison: The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.~H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%